Vydura | European Medicines Agency (EMA)

April 20, 2025

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Overview

Vydura is a medicine used to treat migraine with or without aura (unusual visual or other sensory experiences) in adults. It is also used to prevent migraine in adults who have at least 4 migraines attacks a month.

Vydura contains the active substance rimegepant.

Vydura is available as a freeze-dried wafer to be placed on or under the tongue, where it will dissolve.

Vydura is taken once a day for the treatment of migraine, and once every other day for prevention of migraine.

The medicine can only be obtained with a prescription.

For more information about using Vydura, see the package leaflet or contact your doctor or pharmacist.

A chemical messenger called calcitonin gene-related peptide (CGRP) contributes to the development of migraine. The active substance in Vydura, rimegepant, attaches to the receptor (target) for CGRP. By attaching to this receptor, the medicine prevents CGRP from binding to it. This helps treat migraine and also prevents migraines from occurring.

Vydura was shown to be more effective than placebo (a dummy treatment) at treating migraine in three main studies involving a total of around 3,500 adults. Patients with a migraine attack causing moderate to severe headache recorded the level of pain two hours after treatment using a 4-point Likert scale (0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain).

On average across the three studies, 20% of patients taking Vydura were headache pain-free after two hours, compared with 12% on average for those taking placebo. Vydura was also effective at treating other migraine symptoms such as photophobia (abnormal sensitivity of the eyes to light), phonophobia (abnormal sensitivity to sounds) or nausea (feeling sick): on average, around 36% of patients taking Vydura were free from one of the above symptoms two hours after treatment, compared with around 27% of those taking placebo.

Another study showed that Vydura is effective at reducing the number of days patients suffer from migraines. The study involved 747 adults who had between 4 to 18 migraine attacks a month; patients took Vydura or placebo every other day for up to 12 weeks. Those treated with Vydura had on average 4.3 fewer days with migraines during the last 4 weeks of the study, compared with 3.5 fewer days for patients on placebo.

The most common side effect with Vydura (which may affect up to 1 in 10 people) is nausea. Hypersensitivity (allergic reaction) including dyspnoea (difficulty breathing) and severe rash may affect up to 1 in 100 people.

For the full list of side effects and restrictions of Vydura, see the package leaflet.

Vydura was shown to be more effective than placebo at reducing headaches and other migraine symptoms and at reducing the number of days patients experienced migraine, although the size of the effect is considered modest. The safety profile of Vydura is considered favourable.

The European Medicines Agency therefore decided that Vydura’s benefits are greater than its risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vydura have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Vydura are continuously monitored. Suspected side effects reported with Vydura are carefully evaluated and any necessary action taken to protect patients.

Vydura received a marketing authorisation valid throughout the EU on 25 April 2022.

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First published: 11/05/2022

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Product information

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(483.54 KB – PDF)

First published: 11/05/2022Last updated: 14/04/2025

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Latest procedure affecting product information:
VR/0000254589

11/04/2025

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

English (EN)
(24.43 KB – PDF)

First published: 11/05/2022Last updated: 03/10/2022

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Product details

Name of medicine: Vydura
Active substance: Rimegepant
International non-proprietary name (INN) or common name: rimegepant
Therapeutic area (MeSH): Migraine Disorders
Anatomical therapeutic chemical (ATC) code: N02CD06

Pharmacotherapeutic group

Antimigraine preparations, calcitonin gene-related peptide (CGRP) antagonists

Therapeutic indication

Vydura is indicated for the

Acute treatment of migraine with or without aura in adults;
Preventative treatment of episodic migraine in adults who have at least 4 migraine attacks per month.

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Overview

How is Vydura used?

How does Vydura work?

What benefits of Vydura have been shown in studies?

What are the risks associated with Vydura?

Why is Vydura authorised in the EU?

What measures are being taken to ensure the safe and effective use of Vydura?

Other information about Vydura

Product information

Product details

Pharmacotherapeutic group

Therapeutic indication

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